The present invention relates to an apparatus used for the rupturing of pharmaceutical product packages and the recovery of the product from the package waste. It also relates to the process of pharmaceutical product recovery from its packages. Specifically, the invention relates to a machine for recovering pharmaceutical product from blister packs without damage to that product, and relates to the process carried out in the operation of such a machine.
Pharmaceutical product, such as pills, gel caps, caplets and capsules, sold over the counter, are often packaged in individual pockets on cards. These are known as blister packs and allow the consumer to access one product unit at a time by rupturing an individual pocket. This packaging structure has now found very wide use in the marketplace as it protects the adjacent product from contamination until used, and also allows for a readily discernable count of remaining product vs. product taken.
Blister packaging of pharmaceutical product is presently being provided by automated packaging machinery, including automated filling devices. With increased production rates, increased production line speeds and new product shapes, sizes and coatings, "miss fills" and other blister packaging failures often occur. In some manufacturing lines, as much as 10 to 15 percent of the blister packages of pharmaceutical product are unsuitable for market. The pharmaceutical manufacturers are, therefore, desirous of recovering the miss-packaged product, in good condition for repackaging.
Recovery of this product was originally done by hand. Recently, a number of manufacturers have introduced machines which rupture the unsuitable blister packages and separate the product from the packaging. These manufacturers have included: Sepha Products, Newtownards, N. Ireland; Service Industries Midwest, Inc., Rolling Meadows, Ill.; RBP Maschinevertrieb GmbH, Monschau, Germany; and Roni/Craggs, Inc., Baltimore, Md.
Each manufacturer's design for its product recovery machine has differed, as has the respective machine's method of operation. However, each product recovery machine's design has addressed the same generic blister pack design. A typical, generic, pharmaceutical blister package is a rectangular card having a plurality of regularly spaced plastic product pockets extending upwardly from the card and forming a rectangular product matrix on the card. The card is usually serrated in a cross-hatched fashion to form a plurality of breakaway "cardettes" (i.e. card subsections) each carrying but a single product pocket.
These blister cards are typically made by sandwiching a foil backer material to a preformed plastic sheet carrying the desired plurality of preformed product pockets. Child resistant packages have a paper layer added to the outside of the foil which must be removed before the consumer can open the blister pack. Typically, after the individual product pockets have been loaded with individual product units, the foil backer material, which forms the back surface of the card, is heat sealed with the plastic sheet, either with or without the use of a bonding agent. The foil-to-plastic bond may or may not be mechanically knurled. Following the bonding, the cross-hatched serrations are cut into the flat card surface allowing a space of from about 0.05 inches to about 0.25 inches "margin" between the product pocket wall and a serration. In the instance where the "cardettes" are rectangular, this margin is not uniform about the "cardette" but is equal for opposing edges of the "cardette".
The plastic sheet is made of poly vinyl chloride ("PVC") or other approved material and can vary in thickness from 0.004 inches to 0.010 inches, depending upon the size of the product pocket and the size, weight and strength of a product unit. The foil backer material is typically aluminum foil sheet of about 0.002 inches thickness. This foil is ruptured by the consumer who presses against the product pocket, distorting it and thereby pushing product unit through the foil to release it from the pocket.
When the serrations are cut in a card, the lateral serrations can be die cut first, and the longitudinal serrations can be die cut secondly, or the serrations can all be cut at once. A card is then fed "longitudinally" along the product flow path. With the lateral dimension of a blister pack card being shorter than the longitudinal dimension, a card is stiffer laterally than longitudinally, and will tend to curl along its longitudinal length.
The product pockets are die formed into the PVC sheet while it is in a softened state. These product pocket forming die(s) is(are) tapered so that the cross sectional dimensions of the pocket are larger at its base (where it meets the plane of the sheet) than at the closed end wall of the pocket. The pocket is slightly over sized to provide a space between the wall and a product unit to be carried by that pocket. This space is reasonably uniform about the perimeter of the product and can range from 0.005 inches to 0.075 inches, but is generally in the range of 0.020 to 0.040 inches.
Sepha Products provides a machine which uses a set of rollers to press tablets and capsules from push-through blister packs. The packs are fed from a magazine through the roller set. The product is them separated from the packaging waste material. When child resistant blister packs are involved, having a reinforced backer pull away layer adhered to the back of the blister pack, the blister packs are fed from a magazine stack to a horse-shoe cutting station where the base of the product pocket is cut thereby converting the child resistant pack to a push through pack. The blister pack is then fed through the same roller pair as before, which removes the product from the package by forcing back the wall of the product pocket and releasing the product. The maximum capacity of this machine is about 60 blister packs per minute for straight roller burst, and about 24 blister packs per minute for the pocket cut and roller burst operation.
Service Industries provides a machine which contains a cutting blade structure. This cutting blade simultaneously cuts open each product pocket on a blister pack. The blisters are then cammed open outwardly from the backer card and the product drops into a collection chute. The empty package is then ejected. The maximum capacity of this machine is about 20 blister packs per minute.
RBP provides a machine which processes up to about 30 blister packs per minute from a magazine. It utilizes a roller system, similar to the Sepha roller system, to burst the blister packs. The RBP machine then separates the product from the package waste with a screening operation. The RBP machine does not handle child resistant blister packs.
Roni/Craggs provides a machine which utilizes counter rotating profile rolls to burst the blister pack pockets. Each blister cup (product pocket) is scratched on a "certain spot" to weaken it. The rollers then press the product units through the weakened pocket (cup) wall and the blister pack waste is then separately discarded. Again, the maximum capacity of this machine is about 30 blister packs per minute.
These prior machines focus on single step or "fewer" step operation. They incorporate certain shortcomings into their designs and/or operation, these being: limited capacity, a tendency to jam, a tendency to cut, bruise, break or otherwise injure product.
What is desired is to provide (1) a machine and a method of operation (process) for recovering product from pharmaceutical blister packs which has two to three times the capacity, or greater, of the previous machines.
What is also desired is to provide (2) such a machine which does not easily jam, and (3) which does not cut, bruise, break or injure the product.
What is further desired is to provide (4) such a machine which is easily changed over between various card sizes and product patterns; and (5) which does not require frequent adjustment, synchronization or timing correction.